TIBIAL INSERT

K963028 · Encore Orthopedics, Inc. · JWH · Oct 1, 1996 · Orthopedic

Device Facts

• Record ID: K963028
• Device Name: TIBIAL INSERT
• Applicant: Encore Orthopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 1, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for use of this tibial insert are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques.

Device Story

Tibial insert component for Foundation Knee System; articulates with Foundation Baseplates and Femoral Components. Provides increased congruency compared to primary insert; similar/greater congruency than Foundation Posterior Stabilized Knee. Features increased anterior/posterior lip height for enhanced stability; rotational stability comparable to primary insert. Used in orthopedic surgery for knee arthroplasty; implanted by orthopedic surgeons. Benefits patient by restoring joint function and stability in degenerative or traumatic conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Semiconstrained cemented prosthesis; polymer/metal/polymer construction. Available in seven sizes. Designed for articulation with Foundation Baseplates and Femoral Components.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis), avascular necrosis of femoral condyle, post-traumatic joint loss (with patellofemoral erosion/dysfunction/prior patellectomy), moderate valgus/varus/flexion deformities, rheumatoid arthritis, and fractures unmanageable by other techniques.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Foundation Primary Knee System (K923277)
• Foundation Posterior Stabilized Tibial Inserts (K933539)

Submission Summary (Full Text)

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OCT 1 1996
K963028

# Summary of Safety and Effectiveness

Encore Orthopedics®, Inc.
8900 Shoal Creek BLVD.
Suite 300
Austin, TX 78757
512-206-1437
Ashley M. Bock

**Trade Name:** Tibial Insert
**Common Name:** Tibial Insert
**Classification Name:** Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis

**Description:** This component is available in seven sizes to fit into, and articulate with, the existing Foundation Baseplates and Femoral Components. This device is used in conjunction with the Foundation® Tibial Baseplates and Femurs. This insert is intended to provide more congruency between the insert and femur than is available with the primary insert. However, it will provide similar, or slightly more, congruency than the Foundation® Posterior Stabilized Knee. Anterior/posterior stability is greater than the primary insert because of the increased height of the anterior and posterior lips. Rotational stability is similar to the primary insert.

**Indications:** The indications for use of this tibial insert are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques.

**Comparable Features to Predicate Device(s):** This device is similar in features, design and indications as the Foundation® Primary Knee System (K923277) and Foundation® Posterior Stabilized Tibial Inserts. (K933539)